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Blood, 16 July 2009, Vol. 114, No. 3, pp. 511-517. Prepublished online as a Blood First Edition Paper on May 14, 2009; DOI 10.1182/blood-2009-03-212290. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2009-03-212290v1 114/3/511    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Alousi, A. M. Articles by Levine, J. E. Search for Related Content PubMed PubMed Citation Articles by Alousi, A. M. Articles by Levine, J. E. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted March 24, 2009 Accepted May 3, 2009 Etanercept, mycophenolate, denileukin or pentostatin plus corticosteroids for acute graft vs. host disease: a randomized phase II trial from the BMT CTN Amin M. Alousi*, Daniel J. Weisdorf, Brent R. Logan, Javier Bolanos-Meade, Shelly Carter, Nancy DiFronzo, Marcelo Pasquini, Steven C. Goldstein, Vincent T Ho, Brandon Hayes-Lattin, John R. Wingard, Mary M. Horowitz, and John E. Levine University of Texas M. D. Anderson Cancer Center, Houston, TX, United States University of Minnesota, Minneapolis, MN, United States Medical College of Wisconsin, Milwaukee, WI, United States Johns Hopkins University, Baltimore, MD, United States The EMMES Corporation, Rockville, MD, United States National Heart, Lung and Blood Institute, NIH/DHHS, Bethesda, MD, United States Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin, Milwaukee, WI, United States University of Pennsylvania, Philadelphia, PA, United States Dana-Farber Cancer Institute, Boston, MA, United States Oregon Health and Science University, Portland, OR, United States University of Florida Shands Cancer Center, Gainesville, FL, United States Center for International Blood and Marrow Transplant Research, Froedtert and the Medical College of Wisconsin, Milwaukee, WI, United States University of Michigan, Ann Arbor, MI, United States * Corresponding author; email: aalousi{at}mdanderson.org. Acute graft versus host disease (AGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation (HCT). Corticosteroids remain the standard initial therapy, yet only 25-40% of patients completely respond (CR). This randomized, four-arm, phase II trial was designed to identify the most promising agent(s) for initial therapy for AGVHD. Patients were randomized to receive methylprednisolone 2 mg/kg/day plus etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin) or pentostatin. 180 patients were randomized; median age: 50 years (range, 7.5-70). Myeloablative conditioning represented 66% of transplants. Grafts were peripheral blood (PB, 61%), bone marrow (BM, 25%) or umbilical cord blood (UCB, 14%); 53% were from unrelated donors. Patients who received MMF for prophylaxis (24%) were randomized to a non-MMF arm. At randomization, AGVHD was grade I-II (68%), III-IV (32%) and (53%) had visceral organ involvement. Day 28 CR rates were etanercept 26%, MMF 60%, denileukin 53% and pentostatin 38%. Corresponding 9-month overall survival was 47%, 64%, 49% and 47%, respectively. Cumulative incidences of severe infections were: etanercept 48%, MMF 44%, denileukin 62%, and pentostatin 57%. Efficacy and toxicity data suggest MMF plus corticosteroids is the most promising regimen to compare against corticosteroids alone as initial AGVHD treatment in a definitive Phase III trial. This study is registered at http://www.clinicaltrials.gov as NCT00224874. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: G. Socie and B. R. Blazar Acute graft-versus-host disease: from the bench to the bedside Blood, November 12, 2009; 114(20): 4327 - 4336. [Abstract] [Full Text] [PDF]

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